UK-based medical technology company LivaNova has reported a positive outcome from its RESPOND-CRT clinical trial of SonR cardiac contractility sensor technology to treat advanced heart failure.
The SonR sensor is designed to optimise cardiac resynchronisation therapy by using measurements of cardiac contractility, it consists of a micro accelerometer fitted in the tip of the SonRtip atrial lead.
The optimisation is done on a weekly basis both at rest and during exercise to allow the resynchronisation therapy to be continuously adaptive to the patient’s individual needs.
"RESPOND-CRT was designed as a prospective, multicentre, randomised, double-blind study to determine the safety and efficacy of the SonR system."
It continuously measures the vibrations triggered by the myocardium during cardiac contractions which are correlated to cardiac contractility.
The SonR tip lead is connected to a LivaNova CRT-D device which features an algorithm automatically adapting to the atrioventricular (AV) and interventricular (VV) intervals based on cardiac contractility measurements.
RESPOND-CRT was designed as a prospective, multicentre, randomised, double-blind study to determine the safety and efficacy of the SonR system.
It enrolled 1,039 patients who were implanted with a CRT-D device.
The patients were randomised into a 2:1 ratio to be treated with AV or VV optimisation either with SonR or echocardiography.
Results suggested that the study met its primary endpoints of safety and efficacy which was determined on the basis of a hierarchical set of criteria which were alive, free from heart failure events, with an improved New York Heart Association (NYHA) functional class or quality of life.
University of Barcelona Hospital Clínic cardiovascular institute Professor Josep Brugada said: “We are very pleased to observe the consistent long-term clinical benefits of the SonR optimisation system.
“Reduction of hospitalisation is key for heart failure patients.
"The impressive improvements in cardiovascular clinical outcomes for patients with atrial fibrillation or renal dysfunction show that SonR can treat even even better the sicker patients."